Industry news

• FDA Has Issued Documents Aimed at Guiding the Selection of Proprietary Names for Drugs

  11 December 2020 GMP News

  The US Food and Drug Administration (FDA) has issued a pair of draft guidance documents aimed at guiding the selection of proprietary names for prescription and non-prescription drugs.

• After the Second Dose, the Effectiveness of the “Sputnik V” Vaccine Increases to 96.2%

  11 December 2020 GMP News

  The preliminary data obtained in the Russian Sputnik V coronavirus vaccine trials show that the efficiency of the jab stands at 69.3% after the first component is administered and 96.2% after the second, member of the independent monitoring committee examining the results of the vaccine’s clinical trials Ramil Khabriyev said Thursday (10 December).

• GL Rapha Plans to Launch “Sputnik V” Vaccine Production in January 2021

  10 December 2020 GMP News

  GL Rapha, one of the leading South Korean bio-tech companies, plans to launch full-scale production of Russia’s coronavirus vaccine Sputnik V in January 2021, Maeil Gyeongje newspaper reported.

• EMA and HMA Have Published Their Joint Strategy for the Next Five Years

  10 December 2020 GMP News

  EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for the next five years, following its recent adoption by the HMA and EMA Management Board.

• RDIF and Ministry of Health of Kazakhstan Announce Cooperation on the “Sputnik V” Vaccine

  09 December 2020 GMP News

  The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and the Ministry of Health of Kazakhstan are pleased to announce a cooperation agreement designed to facilitate the registration, production and distribution of the world’s first registered vaccine against coronavirus – Sputnik V.

• The Cost of Two Doses of the “Sputnik V” Vaccine is about 26 Dollars

  09 December 2020 GMP News

  Russia’s Health Ministry has fixed the maximum cost price of the coronavirus vaccine Sputnik V at 1,942 rubles for two doses (about $26.20), Alexei Kuznetsov, an aide to the health minister, told on Saturday (5 December).

• Registration for the COVID-19 Vaccination in Russia Will Open on December 4

  08 December 2020 GMP News

  Registration for inoculation against the coronavirus in Moscow will open on the websites of the Mayor and the Moscow government on December 4; doctors, teachers, and social workers will be the first to get inoculated. Vaccination stations will open on December 5, Moscow Mayor Sergei Sobyanin wrote in his blog on Thursday (3 December).

• Partnership to Discover and Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets

  08 December 2020 GMP News

  AbbVie, a research-based global biopharmaceutical company, and Frontier Medicines, Corp., a precision medicine company drugging challenging protein targets to develop breakthrough medicines that change the course of human diseases, announced a global strategic collaboration to discover, develop and commercialize a pipeline of innovative small molecule therapeutics against high-interest, difficult-to-drug protein targets.

• Free Access to Supportive Pharmacopoeial Texts in the Field of COVID-19 Vaccines Is Open

  07 December 2020 GMP News

  The EDQM is committed to supporting users during the coronavirus disease (COVID-19) pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and providing access to relevant guidance/standards.

• RDIF Announces Investment in Healthcare as a Strategic Priority

  07 December 2020 GMP News

  The Russian Direct Investment Fund, (RDIF) Russia’s sovereign wealth fund, announces RDIF. Healthcare – an investment channel with a strategic focus on the implementation of projects in the healthcare sector. The fund has formed a specialized team of healthcare professionals to lead in developing the channel.